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Therapeutic Drug Monitoring to oPtimize ANtiretroviral regimeNs in HIV-infected Women Who wAnt to Breastfeed

NCT05642481 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2025-12-09

No results posted yet for this study

Summary

This is a prospective, multi-center, longitudinal, mother-infant pair, therapeutic drug monitoring study. The aim of this study is to determine concentrations of antiretroviral drugs in plasma and breastmilk in people living with HIV who chose to breastfeed while using antiretrovirals. At a planned hospital visit an extra maternal blood sample (1 to 2 per visit) and extra infant blood sample (1 per visit) will be collected, as well as a breastmilk sample (1 to 2 per visit). Ideally, sample collection will take place at least during the 1, 3 and 6 month post partum follow up visit. Measured concentrations will be used to calculate milk to plasma ratios, relative and absolute infant dosages.

Conditions

Interventions

DIAGNOSTIC_TEST

Therapeutic drug monitoring in plasma of mother and child and in breastmilk

Measurement of drug concentration in plasma of mother and if possible of child and in breastmilk

Sponsors & Collaborators

  • Amsterdam University Medical Center

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • UMC Utrecht

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05642481 on ClinicalTrials.gov